For women having trouble getting pregnant, the decision to try in-vitro fertilization (IVF) is a big deal. It requires 4 to 6 weeks of almost daily office visits, monitoring, and medication – and after everything’s said and done, the average cost of one IVF cycle is $23,000. Those who can afford it or whose insurance will cover it will often go through 2-3 IVF cycles to increase their chances of successful pregnancy.
Each year, about 1.5% of births in the U.S. are conceived through IVF. Fertility treatment is often recommended even after conception to help support and protect pregnancies. But now, progesterone in oil, an injectable medication that does just that, is facing a shortage.
Since the shortage began relatively recently in August, either the drug makers have not yet reported it to the FDA or the FDA has not yet updated their drug shortages database to reflect it. It is expected to be resolved late December at the earliest, which could affect many newly pregnant women in their first trimester.
What is progesterone in oil and why is it used?
Not to be confused with the two types of shots you have to take during the IVF cycle, progesterone in oil is only used after successful implantation through IVF. Progesterone in oil is an intramuscular injection, meaning you take the shot in the butt cheek. It helps thicken the uterine lining to secure the embryo and allow it to develop properly. A daily dose of 50mL is typically administered for the first 6-12 weeks (or first trimester) of pregnancy, but the dosage and length of treatment may be adjusted depending on how your body reacts to the initial doses.
While progesterone for fertility treatment is available in other forms, like oral capsules (generic progesterone, $23.76) and lozenges (not available retail), or vaginal suppositories (Endometrin, $235.34) and gel (Crinone, $422.50), many physicians consider the injection the first line therapy for women with infertility issues, either on its own or in conjunction with other forms. It’s also the cheapest option at $27.39 through GoodRx.
(In case you’re wondering, the other two shots are typically injected under the skin in the abdomen and thigh. Injections of gonadotropin hormones are taken throughout the IVF cycle to stimulate ovulation, while the human chorionic gonadotropin (hCG) injection is only needed 34-37 hours before the retrieval of the egg. The hCG hormone brings the egg to final maturation and assists in its release from the ovaries.)
What exactly is in shortage and why?
Surprisingly, the progesterone itself is not in short supply. Since the hormone comes as a powder that’s insoluble in water, it needs to be mixed with an oil to make it injectable. And it’s the oil that’s become hard to get – specifically sesame oil, which is the standard used by drug companies to produce the progesterone injection. Pharmaceutical grade sesame oil is considered different from food grade sesame oil (the stuff you find in grocery stores) because only certain production facilities following stricter FDA regulations are approved for drug production.
Since progesterone in oil is not officially reported as being in shortage, there is no way to know why there are limited supplies of sesame oil. But for any drug shortage, there are many factors to consider. Sometimes there’s a lack of raw material or a compliance issue during production. Or maybe the drug isn’t profitable enough for the drug company to prioritize manufacturing. The important thing is that the shortage is temporary, or that there are at least comparable alternatives for patients who rely on the treatment.
What if you need progesterone in oil – now?
Luckily, sesame oil isn’t the only oil used to make the progesterone injection. While leading drug manufacturers like Teva, West Ward, and Fresenius Kabi combine progesterone with sesame oil, some specialty or compounding pharmacies create made-to-order progesterone injections with ethyl oleate or olive oil (this is often done when a patient is allergic or has unwanted side effects with sesame oil). The key difference between the vehicles is the thickness of the oil – thicker oil requires a thicker needle, which may be more painful to use. Olive oil is the thickest of the three, while ethyl oleate is the thinnest.
One compounding pharmacy, MDR Fertility Pharmacy, has boosted their production of both progesterone in olive oil and progesterone in ethyl oleate during this shortage to help women in need of the progesterone injection. Robert Makhani, PharmD, MDR Executive Vice President, says MDR and other licensed sterile compounding pharmacies are working hard to ensure every patient who calls in can secure at least 2-3 vials of progesterone in oil (one vial lasts about 8-10 days). While Dr. Makhani is confident the shortage will end in January at the latest, he says MDR will fulfill orders well into the future, as needed.
Progesterone in sesame oil, brand name Progesterone Injection USP, will most likely be out of stock at your local retail pharmacy, like Walmart or CVS. It’s best to call and check to make sure it’s is available for pickup, even if it’s listed on the GoodRx page. If it’s not and you need it soon, call your fertility clinic to see if they work with any compounding pharmacies, or call MDR directly and mention “GoodRx” for competitive pricing.
Prices shown are average GoodRx discounted prices as of Nov 29, 2017. Local results may vary.